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    Summary
    EudraCT Number:2009-012136-33
    Sponsor's Protocol Code Number:IPH2101-201
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-05-28
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2009-012136-33
    A.3Full title of the trial
    Open randomised phase II study evaluating the anti-tumour activity, safety and pharmacology of two different dose regimens of IPH 2101, a human monoclonal anti-KIR antibody, in patients with multiple myeloma in stable partial response after a first line therapy
    A.4.1Sponsor's protocol code numberIPH2101-201
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInnate Pharma
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/06/392
    D.3 Description of the IMP
    D.3.1Product nameAntiKIR (1-7F9)
    D.3.2Product code IPH2101
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeIPH2101
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody derived from hybridoma cell line
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Multiple myeloma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the clinical activity, measured by M-protein serum and urine levels, of two different dose regimens (0.2 mg/kg, leading to an intermittent saturation of NK receptors and 2mg/kg leading to a sustained saturation of NK receptors) of IPH2101 administered as a single agent in multiple myeloma patients who achieved, after the completion of any first line treatment, including conventional or high dose chemotherapies, a partial or very good partial response (PR or VGPR), stable for at least 2 months.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    o To confirm the safety profile of the dose and administration schedules of IPH2101 in this population;
    o To assess PK of two different dose regimens of IPH2101
    o To evaluate the biological activity of IPH2101 on:
    - KIR occupancy
    - NK cell phenotype
    - NK cell function
    - Cytokine release
    o To confirm the absence of immunogenicity of IPH2101
    o To document per study and post study efficacy parameters until 2 years after the end of study :
    - Overall Survival (OS)
    - Duration of response (DOR)
    - Progression free Survival (PFS) and Time to Progression (TTP)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) MM which initially required a systemic therapy and received a first line treatment, conventional doses of chemotherapies or high dose chemotherapy and an autologous transplantation of hematopoietic cells, followed or not by a consolidation treatment.
    2) Residual disease considered as evaluable with:
    - Quantifiable serum M-protein
    3) Responses which are partial (PR and VGPR) and in plateau
    - Partial response should meet the IMWG uniform response criteria: a ≥ 50% reduction from value of serum M-protein before the first line chemotherapy treatment and a reduction in 24h urinary M protein by ≥ 90% or to < 200 mg / 24h;
    - Very good partial response according to the IMWG uniform response criteria with 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg/24h; Furthermore the M protein should spike in the gamma globulin area;
    - Plateau phase is defined by stable levels of M protein in serum checked 4 weeks apart on at least 3 consecutive samples.
    Fluctuations ± 1 week in sampling and ± 5 % in M protein levels are allowed.
    4) ECOG performance status of 0, 1 or 2
    5) Clinical laboratory values at screening:
    - Calculated creatinine clearance (according to MDRD) > 50 ml/min
    - Platelet > 50 x 109 /l
    - ANC > 1 x 109 /l
    - Bilirubin levels < 1.5 ULN ; ALT and AST < 2.5 ULN (grade 1 NCI)
    6) Male or female patient who accepts and is able to use recognised effective contraception (oral contraceptives, IUCD, barrier method of contraception in conjunction with spermicidal jelly) throughout the study.
    7) Signed inform consent obtained before any trial-related activities
    E.4Principal exclusion criteria
    1) Age < 18 years old or > 75 years old
    2) Previous consolidation/ maintenance therapy by Imid (thalidomide, lenalidomid) or bortezomib within the last 2 months
    3) Treatment with chemotherapy, systemic corticosteroid within the previous 2 months
    4) Treatment with growth factors (EPO, G- or GM-CSF) within the previous 1 month
    5) MM in VGPR with a monoclonal spike in the beta globulin area
    6) Radiotherapy for bone or visceral lesion within the last 3 months
    7) Use of any investigational agent within the last 2 months
    8) Primary or associated amyloidosis
    9) Peripheral neuropathy of grade ≥ III according to the CTCAE of the NCI
    10) Abnormal cardiac status with any of the following
    a) NYHA stage III or IV congestive heart failure
    b) myocardial infarction within the previous 6 months
    c) symptomatic cardiac arrhythmia despite treatment
    11) Current active infectious disease or positive serology for HIV, HCV or positive Hbs Antigen
    12) History of or current auto-immune disease
    13) Serious concurrent uncontrolled medical disorder
    14) History of other malignancy (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma)
    15) History of allogenic hematopoietic cell or solid organ transplantation
    16) Pregnant or lactating women
    17) Any medical condition which is regarded by the investigator as incompatible with the study participation
    18) Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
    E.5 End points
    E.5.1Primary end point(s)
    M Protein will be measured in serum and urine:
    o At Screening
    o Every 4 weeks during the study period from V1-day1 to End of Study
    Post study follow up: then every 3 months during 2 years according to standard practices
    The primary end point will be the rate of patients achieving a response based on M- Protein levels in serum and urine sustained for at least one month.
    Response will be defined:
    o In patients with a serum M-protein > 5 g/l, as a reduction of at least 25% (minor response according to EBMT Appendix VI) from baseline of serum M-protein confirmed on two consecutive determinations at 4 weeks interval;
    o In patients with a serum M-protein ≤ 5 g/l, as a negative electrophoresis
    In any case, a reduction ≥ 50% or a reduction to < 200mg/ 24h in 24h urine M-protein is required.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state42
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 42
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-06-05
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